Dhruvitha Krishna

Similarities and Differences between Medical Device 510(k) and CE Marking

This article highlights some of the similarities and differences between the Medical Device 510(k) and CE Marking regulatory pathways and helps harmonise some aspects of an overall regulatory strategy.
Editor’s Note: This article updates and replaces Vincent Crabtree’s 2014 blog on 510(k) and CE Marking (Pt 1 and Pt 2).

Continue reading »

Sean Mitchell

ESG Medical Device Impact

ESG Medical Device ImpactAs major buyers continue to request Environmental, Social and Governance (ESG) reporting from suppliers, there will continue to be new and revised regulations requiring supply chain attention. Jurisdictions all over the world are increasingly enacting regulations aimed at curtailing the use, import and/or export of certain substances in response to political, environmental and social responsibility concerns. These regulations have far-reaching implications for designers, manufacturers and importers of complex Medical Devices and related equipment.

Continue reading »

Alexandra Reid

Gender Equity in Medical Devices: Bridging the Data Gap

Gender Equity Medical DevicesThe gender data gap of high-quality, gender-specific data represents a critical challenge in healthcare, particularly in the development and efficacy of medical devices for women. Drawing upon Caroline Criado Perez’s insightful work, “Invisible Women: Data Bias in a World Designed for Men,” and the commentary “Medical Devices, Invisible Women, Harmful Consequences,” by Phillips et al. this blog outlines the gender data gap’s implications on women’s health and lists strategic measures for its integration into medical device regulatory frameworks and design processes.

Continue reading »

Helen Simons

4 Regulatory Trends to Watch In 2024

2024 Regulatory Trends

FDA Quality Management System Regulation (QMSR)

In February 2022, FDA released proposals for aligning their Quality System Regulation (QSR) with the commonly used ISO 13485 Medical devices – Quality management systems[1] – Requirements for regulatory purposes. This had been long awaited and was rumoured to be coming for many years prior to this point. As many manufacturers of medical devices and in vitro diagnostics (IVD) were already complying with this standard due to other regulation requirements, it made sense for the FDA to align with this industry ISO standard.

Continue reading »

Alexandra Reid

5 Key Points in FDA’s Real-World Evidence Draft Guidance

FDA Real-World Evidence Draft GuidanceThe FDA is making significant strides in integrating real-world data (RWD) into the regulatory framework for medical devices. A recent 40 page draft guidance, “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” issued by the FDA elaborates on how real-world evidence (RWE) can be effectively used in regulatory decision-making for medical devices.

Continue reading »

Astero StarFish

21 Interview Questions that Work (and Why)

21 Interview Questions that Work
It’s job-hunting season! This blog shares favorite questions and techniques (with the reasoning behind these questions) that our employees have used or encountered for a variety of roles in medical device development. An interesting mix of classics and new twists, we hope they provide inspiration for future interviews and insights into StarFish culture. 

Continue reading »

Astero StarFish

Our Employees’ Resolutions for 2024

Resolutions 2024
Good intentions, diets, exercising and New Year resolutions. Hey, it’s already February! Have you made, started, delayed or abandoned your resolution? No worries. This blog features resolutions and traditions from our employees. May they help inspire you to start the New Year (or February) with positive goals. Before jumping into individual resolutions, let’s start with a lovely tradition from one of our team.

Continue reading »

Joris van der Heijden

Modular Rapid Prototyping for Point of Care Diagnostics

Modular Rapid Prototyping
The past five years have seen mainstream adoption of molecular and lateral flow point-of-care diagnostics. To combat the challenges caused by the pandemic, thousands of diagnostic products entered the market eventually paving the way for an accelerated development roadmap.
Nowadays, entrepreneurs that want to develop lateral flow or molecular diagnostics can simply find a specialized development firm that uses ready-made systems and sophisticated off-the-shelf (OTS) tooling to develop and commercialize a product in record time.

Continue reading »

Nick Allan

Canadian Medtech Entrepreneurs: Reduce your Medical Device R&D costs by 50%

Complete Canadian SR&ED Application5 Easy Steps to Complete a Canadian SR&ED application

The Scientific Research and Experimental Development (SRED or SR&ED) Tax Incentive Program has long been the unsung hero of many of Canada’s science and technology development Cinderella stories. The Canadian SR&ED program provides support in the form of tax credits and/or refunds, to corporations, partnerships or individuals who conduct scientific research or experimental development in Canada.
An important part of Canada’s economic engine since 1944, this tax incentive is the government’s largest single support program for R&D. Annually, this program provides over $3B to over 20,000 companies in Canada making it one of the more generous R&D programs among Organization for Economic Cooperations and Development (OECD) countries.

Continue reading »

Khaled Youssef

One Platform, Versatile Solutions: Introducing a Modular Platform.

Introducing a Modular PlatformImmunoassays are the heart of most bioanalytical techniques used in clinical and research settings, allowing for accurate detection and quantification of biomolecules.
The detection and quantification of an analyte is achieved using capture reagents, usually antibodies or antigens. The binding interactions between the analyte and the capture reagent are highly sensitive and specific, allowing for accurate and precise measurements.

Continue reading »

Gary Skarja

Powering Future Cell and Gene Therapy Manufacturing

Cell Gene Therapy ManufacturingBiomanufacturing tools providers play a vital role by developing novel technologies and products to drive down manufacturing costs. This blog discusses 3 areas of technology powering the future of cell and gene therapies (CGT) manufacturing with design and development insights for each area: decentralized manufacturing, closed & automated systems and single-use technologies.

Continue reading »

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.

Website Survey

Please answer a few questions about our website.

Take Survey No Thanks